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Набор скоро начнётся NCT07033949

Effect of Green Light Exposure at Different Times on the Pain of Subjects

Без фазы С лечением Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Green light glasses, Transparent light exposure.
Кому может быть актуально
Состояния в реестре: Pain. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Randomized Controlled Study on the Effect of Green Light Exposure at Different Times on the Pain of Subjects

Обзор

Patients who met the criteria and needed to undergo elective surgery via arterial and venous puncture were included in this center. They were randomly divided into three time periods (8:00-9:00, 12:00-13:00, 16:00-17:00) and were exposed to green light (experimental group) and transparent light (control group) respectively. The effects of green light exposure on acute perioperative pain in patients were observed at different times.

Подробное описание

Random numbers were generated by the computer to randomly assign patients who met the inclusion and exclusion criteria to the experimental group (exposed to green light) and the control group (exposed to transparent light). The patients were randomly assigned to three time periods (8:00-9:00, 12:00-13:00, 16:00-17:00) to receive a colored exposure with glasses: Therefore, in order to minimize bias and expectations, it was not informed to the patients which color would affect the pain during the arterial puncture. The patients rested in the pre-anesthesia room for 5 minutes, their heart rate (HR) was measured, and a pain sensitivity test (tender point) was conducted. Then, the patients wore the trial glasses and stayed in the pre-anesthesia room for 30 minutes, and they underwent arterial and venous punctures. While monitoring the patients' heart rate, the catheterization of the arterial and venous punctures was performed. Then, during the arterial and venous puncture, their pain scores (NRS) were recorded separately.

exposed to green light (green group) for 30 minutes. The above operation will be repeated to measure the patient's pain threshold.

Вмешательства

  • Устройство Green light glasses
    Exposure to green light for 30 minutes
  • Устройство Transparent light exposure
    Exposure to transparent light for 30 minutes

Первичные конечные точки

  • Pain intensity during arteriovenous puncture [Срок оценки: The pain score during arterial puncture which about 2-3min]
Вторичные конечные точки (4)
  • Pain sensitivity [Срок оценки: from the time before to 30 min after light exposure]
  • Analgesic consumption during surgery [Срок оценки: From surgery beginning to the ending of the surgery]
  • Pain intensity after surgery [Срок оценки: From ending of the surgery to 24 hours after surgery]
  • Analgesic consumption after surgery [Срок оценки: From ending of the surgery to 24 hours after surgery]

Критерии участия

Критерии включения

  • Age range: 18 - 50 years old.
  • ASA classification: I - III.
  • Planned to undergo abdominal surgeries requiring general anesthesia and arterial puncture (this is not necessary for the healthy volunteer group).
  • Obtained informed consent from the patients.

Критерии исключения

  • Skin ulceration, allergic reactions, or dermatitis at the tested area.
  • Long-term use of analgesics or psychiatric medications.
  • History of color blindness or uncorrected cataracts.
  • Severe cardiovascular or respiratory diseases, inflammatory disorders, etc.
  • Failure of the first arterial puncture.
  • Communication difficulties, etc.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT07033949 · GLE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗